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Bristol-Myers Squibb Company (BMY)

Q3 2009 Earnings Call· Thu, Oct 22, 2009

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Transcript

Operator

Operator

Good afternoon ladies and gentlemen my name is Stephanie and I will be your conference operator today. At this time I would like to welcome everyone to the Third Quarter 2009 Amylin Pharmaceuticals Inc. Earnings Conference Call. (Operator Instructions). I would now like to turn the conference over to your host for today Mr. Michael York, Senior Director of Finance and Investor Relations. Please proceed.

Michael York

Management

Good afternoon and welcome to Amylin Pharmaceuticals Quarterly Update Conference Call. Today's discussion will contain forward-looking statements that involve risks and uncertainties. These risks and uncertainties are outlined in today's press release and in our recent filings with the Securities and Exchange Commission. Our actual results could differ materially from what is discussed on today’s call. Also, we have uploaded a presentation on our website that provides additional background on the quarter. Let me introduce the other members of the Amylin management team here today. Daniel Bradbury, President and Chief Executive Officer; Mark Foletta, Senior Vice President, Finance and Chief Financial Officer and Vince Mihalik, Senior Vice President, Sales and Marketing and Chief Commercial Officer. I will now turn the call over to Dan Bradbury.

Dan Bradbury

Management

Thanks Michael and welcome to our third quarter call. Earlier today we released our operating results for the quarter. We maintained stable revenue quarter-over-quarter while implementing our new commercial model we discussed on our last quarterly call. We are starting to see the benefit of the increased operating leverage and enhanced productivity that have resulted from the actions we have taken over the past year. Indeed this quarter the Company generated non-GAAP operating income. This afternoon our comments will build on the press release issued earlier today. n a few moments Mark will provide additional details on the quarters underlying financial results and comment on our outlook for the remainder of the year. Vince will then review our commercial activity for the quarter and highlight our plans for the future. Before I turn the call over to Mark I will provide an update regarding third quarter performance with respect to the five priority areas to drive shareholder value that I outlined at the start of the year. The first area of value creation is BYETTA. While we were building out the exenatide 1 team and deploying our specialty sales force during the third quarter we were able to maintain stable revenues relative to the second quarter of this year. Recall that exenatide 1 is a single integrated Amylin Lily business unit located in San Diego and our restructured sales team is designed to better address the needs of physicians who treat the significant number of patients with type 2 diabetes. From a regulatory perspective we have an application into the FDA for a monotherapy indication. We continue to have constructive dialogue with the agency and I remain confident that it will be approved in the near future. The second area of value creation is exenatide once weekly. The review of…

Mark Foletta

Management

Thanks Dan, and good afternoon. I will provide an update on our third quarter results and financial guidance for the remainder of the year. As Dan mentioned and discussed in previous calls, we are managing the business aggressively, focused on generating sustainable, positive operating cash flow and maintaining a strong cash position. As I have discussed over the last several quarters, the key metric to track our financial progress is non-GAAP operating loss. We believe that this metric is an important measure of the performance of our business. Non-GAAP operating loss approximates our use of cash for operations before working capital changes as we drive towards our stated goal of sustainable, positive operating cash flow by the end of 2010. As a reminder, non-GAAP operating loss is defined as our GAAP operating loss adjusted for non-cash items including equity compensation, depreciation and amortization, and any one time items such as restructuring charges. We reported non-GAAP operating income of approximately $0.6 million this quarter. This compares to a non-GAAP operating loss of $32.7 million for the same period in 2008. Total revenue was $211.2 million including net product sales of $192.9 million in the third quarter, compared to total revenue of $218.4 million including net product sales of $201.4 million for the same period in 2008. Product sales in the third quarter were $171.1 million for BYETTA and $21.8 million for SYMLIN. BYETTA sales were down $4 million compared to last quarter due to a modest increase in wholesaler inventories last quarter. Wholesaler inventories at September 30 were comparable to those at June 30. Excluding the impact of stocking on second quarter sales BYETTA product sales were comparable quarter-over-quarter and in line with stable prescription levels in the third quarter. Cost of goods sold was $22.6 million reflecting a gross margin…

Vince Mihalik

Management

Thank you, Mark. Amylin sales and marketing organization remains focused on our day-to-day business driving 2009 revenue and advancing our longer-term commercial strategy: our third quarter results reflect this focus. I will start my remarks discussing some operational advances before diving into progress by product. Last quarter I highlighted that we merged Amylin’s existing primary care and specialty sales forces into a single sales organization that would bring a more highly trained specialty approach to endocrinologists and diabetes focused primary care physicians. As a reminder, our specialty field sales organization now includes approximately 325 sales representatives focused on endocrinologists and other physicians who treat significant numbers of diabetes patients. I am pleased to report that the changes to our sales force are fully implemented. Over the course of the third quarter we observed an improvement in sales effectiveness as our specialty representatives worked their way through new territories and target lists. We strongly believe that a substantial amount of new training for our sales representatives, which they received in the third quarter, has transformed our sales force. We are committed to this intensive training for our field teams that will position them as a valuable resource to help physicians better achieve outcomes for their patients with type 2 diabetes. Additionally, our exenatide-1 business unit is in place and focused on growing BYETTA as preparations for the launch of exenatide once weekly continue. Now I will provide brief updates on in-line products starting with BYETTA. As a reminder, BYETTA is the first and only FDA approved GLP-1 receptor agonist available on the market. BYETTA occupies a unique place in the treatment of type 2 diabetes by addressing specific unmet needs with the dual benefits of powerful glucose control with potential weight loss supported by a low risk of hypoglycemia. Even with…

Dan Bradbury

Management

Thanks, Vince. I will add just a few more updates before we close. As I mentioned earlier our obesity program represents the fourth area focus in our plan for value creation for Amylin in 2009. During the third quarter we announced positive results from a 28-week dose ranging study of the combination therapy pramlintide/metreleptin to treat overweight and obese patients. This Phase II study successfully characterized patients who responded best to treatment and also provided important information to informed dose selection. By the end of this year we will report data from the extension to this study. In our other clinical program focused on obesity we remain on track to complete the davalintide Phase II study later this quarter. We will finalize our obesity development and funding strategy based on the outcomes of these studies. Also during the quarter we entered into an agreement with Biocon to jointly develop, manufacture and commercialize the novel peptide therapeutic for the potential treatment of diabetes. The technology at the center of this agreement is our peptide hybrid or fybrid technology which enables the fusion of two different peptides with unique attributes or synergies. Fybrids encompass dual pharmacology in a single molecular entity and provides the benefits of less complicated manufacturing in clinical development programs. I am exited about this agreement because enables us to access Biocon’s world class manufacturing expertise and move the program forward in an expeditious manner. Amylin and Biocon will collaborate the therapeutic potential of this fybrid compound and share development costs. This is consistent with our strategy to pursue options that enable advancement of our early stage programs while sharing technical and financial risks. Also during the quarter our Board of Directors elected Paulo Costa as Chairman. Paulo is the former President and Chief Executive Officer of Novartis US…

Operator

Operator

(Operator Instructions) Your first question comes from Cory Kasimov from J.P. Morgan.

Mona Nilsson - J.P. Morgan

Analyst

This is actually Mona for Cory. My first question is actually on the 120-day safety update. I was wondering if you are in a position to share the data from how many patients in the DURATION studies were actually included in that update?

Dan Bradbury

Management

I am not in a position to share that information. Just to say that the 120-day update was consistent with the FDA regulations around their requirement for 120-days which is all of those patients that would be completed within the period of time according to the regulation which is a number of months prior to that date.

Mona Nilsson - J.P. Morgan

Analyst

Okay and then I realize the data from the DURATION-4 and 5 studies are going to be available in 2010, but are you in a position to put a refined timing on that?

Dan Bradbury

Management

At this time we are not providing any more specific guidance on DURATION-4 and 5 with the exception of 5 which we are expecting in the first half of 2010.

Mona Nilsson - J.P. Morgan

Analyst

Okay, thanks very much.

Operator

Operator

Your next question comes from Jason Zhang of BMO Capital Markets.

Jason Zhang - BMO Capital Markets

Analyst

I jumped in a little late and I am wondering how much you have talked about your – you submitted the 120-day safety update and you also announced a cardiovascular trial for exenatide. Do you envision using that as a fulfillment for the cardiovascular requirements? I mean how has that trial played out in this whole process? Do you plan that trial primarily for actually showing the cardiovascular benefit or you might actually use that trial as a fulfillment for the cardiovascular risk mitigation before the potential approval?

Dan Bradbury

Management

That is a great question. The cardiovascular outcome study has been specifically designed to demonstrate superiority relative to other diabetes therapies in showing an improvement in outcomes with respect to cardiovascular events. It is not being designed with a view towards answering the regulatory requirement. We announced previously, earlier this year, the analysis that we had done on the entire exenatide database demonstrating that there was no increase in cardiovascular risk associated with exenatide therapy; that analysis was updated as part of the 120-day update. Consistent with the agency’s request in our 74-day letter to do a combined analysis looking at all exenatide therapy, which is both BYETTA and exenatide once weekly, as part of the assessment of cardiovascular risk.

Jason Zhang - BMO Capital Markets

Analyst

On the capital expenditure you just mentioned you are lowering your guidance for this year from previously $125 to $100 to develop the pen for exenatide. Have you updated your timeline for that program? Are we supposed to see that program complete by 2012 or is that your end place?

Mark Foletta

Management

I think you should think of the adjustment of the capital guidance in 2009 as just the timing of cash flows. The program remains on track with really no change in the timeline of when we expect to have the pen available.

Jason Zhang - BMO Capital Markets

Analyst

That is originally planned to be completed by 2012, right?

Dan Bradbury

Management

Our guidance actually specifically was within two years of the launch of exenatide once weekly which would be consistent with what you are saying if EQW is approved next year.

Jason Zhang - BMO Capital Markets

Analyst

Okay thanks.

Operator

Operator

Your next question comes from Thomas Russo of Robert W. Baird & Co. Ryan - Robert W. Baird & Co.: This is actually Ryan for Tom. I have a question about the status of the label updates. Can you specify what external to Amylin is factoring into that and whether the critical path is currently going through the agencies review of other GLP-1s?

Dan Bradbury

Management

We have continued to have constructive dialogue with the agency and the agency continues to be open to the receipt of information from us. In terms of the timeline and what is taking such a length of time, I really cannot speculate with regards to the agency’s workload and what may be affecting that. All I can say is that I would reiterate that we remain confident that the indication will be approved for monotherapy and that we expect to see the label update in the near future. Ryan - Robert W. Baird & Co.: Okay and then just a follow up, as part of the 120-day update can you share any interactions you have had regarding the sufficiency of the animal toxin carcinogenicity data that you provided and what if anything you are looking for in addition?

Dan Bradbury

Management

With regards to the 120-day safety update as we reported on the last earnings call the requirements for the 120-day safety update were actually specified in the day 74 letter that we got. That letter was consistent with our expectations. They did not ask us for any additional pre-clinical or clinical studies during that letter. The 12-day update requests were consistent with the line extension strategy and the agency indicated at that time that the PDUFA date would be in the first quarter of 2010. With regards to additional interactions with the agency, at this time I cannot comment on any additional interactions except to say that all of the interactions that we are continuing to have with the agency are consistent with the agency continuing the review according to the PDUFA timeline. Ryan - Robert W. Baird & Co.: Okay thanks.

Operator

Operator

Your last question comes from Terence Flynn of Lazard Capital Markets.

Terence Flynn - Lazard Capital Markets

Analyst

I was just wondering if you could provide us any more details on the design of the DURATION-6 trial with regards to is it going to be a non-inferiority or superiority design. Also, the geography of the trial, is it going to be an x-US study or is it going to be a worldwide trial?

Dan Bradbury

Management

As you know DURATION-6 is the latest in the DURATION superiority study series so specifically this study is designed to demonstrate superiority of exenatide once weekly head-to- head with Liraglutide in regards to glucose control. This study will be conducted in multiple sites across the globe, so I can’t give you too many details on that, but to say that our expectation is that it will be approximately around 900 patients will be involved in the study design. We believe that with the efficacy that we have seen in the DURATION program to date that we have a great opportunity here to demonstrate the superiority of exenatide once weekly with regards to Liraglutide and we are very excited about the potential outcome for this study.

Terence Flynn - Lazard Capital Markets

Analyst

Okay, thanks a lot.

Operator

Operator

I would now like to turn the call over to Mr. Dan Bradbury, President, and CEO for closing remarks. Please proceed.

Dan Bradbury

Management

I would like to thank everybody for their interest and for the questions that we have received today. As I mentioned in my closing remarks in the pre-prepared remarks, we do have a great opportunity, I believe, going forward to continue to advance our mission in the fourth quarter of this year of discovering and developing and commercializing medicines that improve the lives of people with diabetes. I would also like to reiterate the fact that our leadership team and the dedicated employees of Amylin remain focused both on building the business today, as well as laying the necessary foundation for success tomorrow. If any of you have any additional questions following the call please call Michael York, our head of our Investor Relations Team. Thank you very much.

Operator

Operator

Ladies and gentlemen that does conclude the conference call for today. We thank you for your participation. (Operator Instructions)